Drug Interaction:
Immunosuppressant drugs include-
Azathioprine, Tacrolimus (FK 506 ), Mycophenolate Mofetil, Cyclosporine, Muromonab -CD3,
Interacting drugs- summary
+Cyclosporine-
Carbamazepine /phenobarbital/pheytoin/rifampin/rifabutin
decreased half-life and blood levels, possible of transplanted organ
Sulfametazine/ trimethoprin IV
decreased serum levels and possible rejection of transplated organ
Diltiazem /erythromycin/fluconazole/ ketaconazole/ nicardipine
increased half-life, blood levels and immunosuppression,possible nephrotoxicity
Imipenin -cilastin
increased blood levels and CNS toxicity
Methylprednisolone
increased plasma levels
High dose prednisolone
decreased blood levels
Metoclopropamide
increased bioavailability and plasma levels
Amiodranone
increase in blood concentration, possible nephrotoxicity
Danazol/ Methyl estostreone
increased blood concentration with possible nephrotoxicity
Nicardipine
increased through blood levels and possibly nephrotoxicity
Acetazolamide
increased trough cyclosporine levels with possible toxicity
( nephrotoxicity ) may occur
Indication:
Prophylaxis of organ rejection in kidney.iver, and heart allogenic transplants
LIST OF DRUGS DURING 2006
Sr.No- 55
Name of the Drug- Cyclosporin Eye drops (0.1%) (addl.stgth) Pharmacological Classification- For Ophthalmic use
Date of Approval- 02-06-2006
Approved by U.S.FDA on 30-12-2006 (Ref- FDA approved List- 2006)
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Cyclosporine Immunosuppressant June 1998
2. Cyclosporine Eye Drops 0.1% 02-06-2006
Addl Strgth
For opthalmic use
Adverse Reaction:
Anaphylactic reactions, Hypertension, Anorexia, gastritis,
Peptic ulcer, hiccups, mouth sores. Allergic reactions, Anemia,
Conjuntivitis, Edema, Fever, Hearing loss, Hyperglycemia, Muscle pain
Contra-Indications:
Hypersens to polyoxyethylated castor oil.
Special precautions:
Blood level monitoring, patients with malabsorption, hypertension
Dosages/ Overdosage Etc:
Prophylaxis of organ rejection in kidney.iver, and heart allogenic transplants
Overdosage-
Symptoms
Sanimmune is slowly absorbed.
Transcient hepatotoxicity/nephrotoxiciy may occur
Treatment
1. Follow general supportive treatment
2. Cyclosporine is not dialyzable to a great extent, nor cleared by charcoal hemoperfusion
Missed dose-
1. If you miss a dose of this medicine, take it as soon as possible.
2. However, if it is almost time for next dose, skip the missed dose and go back to your regular dosing schedule.
3. Do not double doses.
Other Information:
For Availability/supplies
Contact -
1.Indian Drug Manufacturers Association (IDMA)
Phone- 022- 24944624/ 24974308
Fax- 022- 24950723
Email- idma@vsnl.com
Website: www.idma-assn.org
2.Bulk Drug Manufacturers Association (India)(BDMA)
Phone - 040-23703910/ 23706718
Fax- 040-23704804
Email- info@bdmai.org
Website: www.info@bdmai.org
Patient Information:
1. To improve flavour of the oral solution, dilute with milk, juice at room temperature.
2. See your physician regularly.
3. Any change in cyclosporine formulation, should be done with physicians advise.
4. Use mechanical contrceptive measure during cyclosporine treatment. Do not use oral
contraceptives
5. Advise patients to take cyclosporine on a consistent schedule with regard to the time of the day
and relation to meals.
6. Allergies- Tell your doctor if you have ever had any unusual or allergic reactions to cyclosporine or
other related medicines. Also tell your doctor if youn are allergic to any other substances such as
foods, preservatives or dyes.
7. Pregnancy- studies have not been in humans. However studies in rats and rabbits have shown that
cyclosporine at toxic doses (2 to 5 times the human dose) causes birth defects or dath of fetus
8. Breast feeding- it may be necessary to stop breast feeding during treatment. Be sure to discuus
this with the doctor.
9. Children- not reported to cause different side effects or problems in children than adults
10.Elderly- not expected to cause different side effects in older people tan it does in younger adults
11. Other medicines- tell your doctor if you are taking any of the following-
Amiloride or Spironolactone or Triamterene - since both cyclosporine and triamterene increase the amount of potassium in the
body, potassium levels could become too high.
Androgen or Cimetidine or Danazol or Diltiazem or Erythromycin or Estrogens or
Ketoconazole - may icrease effects of cyclosporine by increasing the amount of this medicine
in the body
Azathioprine or Chlorambucil or Corticosteroids or Cyclophosphamide or Mercaptopurine or
Muromonab - CD ( monoclonal body ) there may increased risk of infection and cancer because
both cyclosporine and these medicines decrease the bodys ability to fight them
Lovastatin - may increase the risk of kidney problems
12. Other medical problems- tell your doctor if you have any other medical problems-
Chickenpox or Herpes zoster -risk of severe disease affecting other parts of the body
Infection- cytarabine can decrease your bodys ability to fight infection.
Intestine problem effects may be decreased because cyclosporine cannot be absorbed in the
body
Kidney disease- cyclosporine can have harmful effects when taken for a long time
Liver disease - effects of cyclosporine may be increased because of slower removal from
the body.
8. Missed dose-
If you miss a dose of this medicine take it as soon as possible. However if it is almost time
for your next dose, go back to your regular dosing schedule.
Do not double doses.
Pharmacology/ Pharmacokinetics:
Pharmacology:
Cyclosporine is a cyclic polypeptide immunosuppressant consisting of 11 amino acids. The action is based on reversible inhibition of immunocometant lymphocytes in the phase of cell cycle. It does not cause bone marrow suppression.
Pharmacokinetics:
The absorption from the GI tract is incomplete and variable. The extent of absorption is dependent on the individual patients.
Interaction with Food:
Take consistently with regard to time of day and relation to meals.
Avoid Grape juice
Pregnancy and lactation:
Pregnancy:
Safety for use during pregnancy has not been established. Use with caution.
Lactation:
Avoid nursing; cyclosporine is excrteted in breast milk.